Medical Devices Regulation (MDR)

Regulation (EU) 2017/745 on medical devices aims to:

  • Ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
  • Set high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.

MDR has led to major or minor changes in areas such as:

  • supervision of notified bodies,
  • conformity assessment procedures,
  • clinical investigations and clinical evaluation,
  • vigilance,
  • market surveillance,
  • transparency and traceability.

The regulation also deals with areas such as:

  • uncertainty about the risks and benefits of nanomaterials,
  • healthcare software,
  • the ability of healthcare facilities to manufacture, adapt and use devices in-house, thus addressing the specific needs of target patient groups,
  • introduction of a medical device monitoring system,
  • setting up a risk management system and reporting adverse events,
  • linking the risk management and clinical trial process,
  • traceability of medical devices through unique identification,
  • improving access to information – Eudamed database,
  • strengthening the position of notified bodies,
  • tightening and streamlining conformity assessment procedures,
  • systematic monitoring of information concerning the experience with the use of medical devices,
  • and many others.